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Analytics in Solid State Chemistry: What You Need to Know

Solid state chemistry is fundamental to the development of a pharmaceutical compound into a drug product, and understanding analytics is crucial to successfully addressing any challenges that can occur in a product’s lifecycle. In solid state chemistry specifically, the physical and chemical (PhysChem) analytics will show which properties need to be improved to help ensure the highest chances of success: purity, stability, solubility, or bioavailability.

In drug development, knowing the characteristics of each form of the active pharmaceutical ingredient (API) is essential in order to select the most suitable form for production. For the research chemist, the PhysChem purity is one of the most crucial requirements. Furthermore, selection of the thermodynamically most stable polymorph; low hygroscopicity measured by dynamic vapor sorption (DVS); consistent crystallinity measured using X-ray powder diffraction (XRPD); sharp single melting event determined by differential scanning calorimetry (DSC); and low levels of residual solvent by thermogravimetric analysis (TGA) are all part of the ranking criteria. Aqueous solubility and dissolution rate are indispensable for the route of delivery and dosage form.

Topics: Thought Leadership Solid State API

Crystallization in Solid State Chemistry

Solid state chemistry plays a major role in successfully developing a compound into a drug product. The physical and mechanical properties are important in selecting the most appropriate stable form with sufficient solubility. The occurrence of crystallization from a crude reaction mixture is the first step towards obtaining a pure drug substance.

For process chemists crystallization is an essential tool for isolation and purification of the compound in a robust and reproducible way. In addition, the crystallization conditions impact the crystal form or polymorph, particle habit, and its characteristics like stability and bio-availability. Optimized pharmaceutically-acceptable crystallization conditions are established by varying cooling profile and slurry conditions, by adding anti-solvent, or by applying seeding to obtain the preferred form, if needed.

Topics: Solid State API Crystallization

The 6 Pillars of Solid State Chemistry

Solid state chemistry is the study of the synthesis, crystal structure, and properties of solid phase materials. This area of inquiry and analysis is particularly relevant to explore the properties of oral solid dosage formulations.

In the graph provided below, the six pillars of solid state chemistry are illustrated with subcategories included to give further understanding of what solid state chemistry encompasses. Alcami fields this combined experimental and analytical capability through its own Center of Excellence (CoE) for solid state chemistry and crystallization, which is located in its active pharmaceutical ingredient (API) development facility in Weert, Netherlands.

Topics: Solid State API

Top 7 Benefits of the Bruker D8 DISCOVERY HTS™

The D8 DISCOVER HTS combines advanced sample analysis throughput capabilities with great flexibility. This highly innovative system perfectly matches the application requirements of the pharmaceutical industry for crystallization studies, polymorph screening, structure solution, phase identification and crystallite size determination under ambient and non-ambient conditions. With its unparalleled high-throughput screening capability, the D8 DISCOVER HTS provides opportunities for optimization of the development and production of pharmaceuticals 

This state-of-the-art equipment at Alcami's Center of Excellence for Solid State Chemistry in Weert, Netherlands enhances our end-to-end service offering, helping clients meet significant milestones and maintain stability in drug development.

Topics: Solid State

ON-DEMAND WEBINAR: Accelerating Drug Development through Automation

Join Alcami for a webinar to learn more about accelerating drug development through automation.

Drug development is based on making the right decisions at the right moment; where R&D focuses on providing that information as rapidly as possible. At Alcami, we use automation as a tool to provide the overall design space of the reaction sequence, form selection and crystallization from gram to multi-kilogram scale. The approach of combined Principle Component Analysis (PCA) and Design of Experiments (DoE) provides a broad overview, with a high diversity in conditions and optimal route for further development. The integrated process chemistry, analytics and pre-formulation allow for a parallel approach to the program that shortens timelines without the loss of information due to transfer between departments and/or companies. The seamless integration of these activities eliminates unnecessary repetition of what has worked before by secondary labs and keeps the research at Alcami focused on finding the best overall conditions to optimize quality and quantity.

Topics: Webinars Solid State

Alcami Invests in Bruker’s D8 DISCOVER HTS™ System for High-Throughput X-Ray Diffraction Screening in Pharmaceutical Formulation Development

Weert, The Netherlands and Karlsruhe, Germany – March 3, 2017 – Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, and Bruker AXS, one of the world's leading suppliers of analytical X-ray solutions, today announced the delivery of Bruker’s D8 DISCOVER HTS™ high-throughput X-ray Diffraction (XRD) analysis system to the Alcami site in Weert, The Netherlands.

Topics: Company News Solid State

ProForm Select™ Integrated Offering for Solid State Chemistry and Formulation Development

Wilmington, NC –February 4, 2016 – Alcami, a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries announces ProForm Select™, an integrated service offering for solid state chemistry and formulation development to help the pharma/biotech industry meet important milestones and maintain stability in drug development. ProForm Select™ aligns our solid-state, process chemistry and formulation development centers of excellence in Weert, Netherlands, Germantown, Wisconsin and Wilmington, North Carolina. This service is ideal for customers with preclinical small molecules in development. These groups are focused on designing efficient, robust and scalable processes to progress Active Pharmaceutical Ingredients (APIs) from early development to final dosage form. 

Topics: Company News Solid State Formulations

Freeslate Powder Dispensing System Is Selected To Increase Solid State Capabilities

SUNNYVALE, CA & WILMINGTON, NC – September 30, 2015 – Freeslate, Inc., the leading provider of high throughput research solutions for biopharmaceutical development, today announced that AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML) has acquired a CM Protégé Powder Dispense System to support its existing Freeslate Core Module system for solid state screening and characterization. As Contract Development and Manufacturing Organizations (CDMOs) continue to adopt automation, AAI/CML is leading the way by deploying reliable, modular Freeslate systems dedicated to solid state screening and characterization to greatly increase the quality and capacity of work within its Weert, Netherlands facility.

Topics: Company News Solid State